FDA.reportPublic FDA data

AXIV Allergy

Manufacturer
VIVUNT PHARMA LLC
Effective date
2025-09-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:13:58

Label at a glance#

ProductAXIV Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage and administration

Take every 4 to 6 hours, or as directed by a doctor Do not take more than 12 Softgels in 24 hours for Adults and children 12 years and over. Do not take more than 6 Softgels for children 6 to under 12 years of age in 24 hours. adults and children 12 years and over 1 or 2 Softgels children 6 to under 12 years 1 Softgel children under 6 years do not use

Storage and handling

Store at 20° - 25 °C (68 °- 77 °F) Read all product information before using Tamper Evident: Do not use if the foil printed on the blister is torn or ripped. Tamper Evident: Do not use if carton or pouch is open

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredient (in each softgel)Purpose
Diphenhydramine HCl 25 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Overdose Warning

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take every 4 to 6 hours, or as directed by a doctor
  • Do not take more than 12 Softgels in 24 hours for Adults and children 12 years and over. Do not take more than 6 Softgels for children 6 to under 12 years of age in 24 hours.
adults and children 12 years and over1 or 2 Softgels
children 6 to under 12 years1 Softgel
children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • Store at 20° - 25 °C (68 °- 77 °F)
  • Read all product information before using
  • Tamper Evident: Do not use if the foil printed on the blister is torn or ripped.
  • Tamper Evident: Do not use if carton or pouch is open

Inactive ingredients

INACTIVE INGREDIENT SECTION

Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

SPL UNCLASSIFIED SECTION

*This product is not manufactures or distributed by Johnson & Johnson Consumer INC, owner of the registered trademarks Benadryl® Allergy Liqui-Gels®

Distributed by: VIVUNT PHARMA LLC

SPL UNCLASSIFIED SECTION

8950 SW 74th Court, Suite 1901

Miami, FL 33156-3178

Made in India.

www.vivunt.live

PRINCIPAL DISPLAY PANEL 24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Benadryl® Allergy Liqui-Gels®

active ingredients*

NDC 82706-019-01

AXIV Antihistamine

  • Runny Nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Throat

DYE-FREE

Diphenhydramine HCl

24 SOFTGELS** **Liquid-filled capsules

AXIVALLER1AXIVALLER1

Allergy Relief 50 softgels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Benadryl® Allergy Liqui-Gels®

active ingredients*

NDC 82706-019-03

AXIV Antihistamine

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat

DYE-FREE

Diphenhydramine HCl

50 SOFTGELS** **Liquid-filled capsules

ALLERGY 50 SOFTGELSALLERGY 50 SOFTGELS22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN4
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-019-01AXIV Allergy2 in 1 CARTONCAPSULE, LIQUID FILLED24
82706-019-01AXIV Allergy12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
82706-019-02AXIV Allergy3 in 1 CARTONCAPSULE, LIQUID FILLED34
82706-019-02AXIV Allergy2 in 1 POUCHCAPSULE, LIQUID FILLED24
82706-019-03AXIV Allergy25 in 1 CARTONCAPSULE, LIQUID FILLED254
82706-019-03AXIV Allergy25 in 1 BLISTER PACKCAPSULE, LIQUID FILLED254

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82706-01982706-019-01, 82706-019-02, 82706-019-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLPARABENZ8IX2SC1OHIACT
GELATIN2G86QN327LIACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AXIV AllergyDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1323a67c-b9c5-038c-e063-6394a90a5e6b2025-09-17WarningsExact identifier
ndc (package): 82706-019-03
ndc (package): 82706-019-01
ndc (package): 82706-019-02
ndc (product): 82706-019
ndc11 (package): 82706001902
ndc11 (package): 82706001901
ndc11 (package): 82706001903
spl id: 3f023cd0-2567-63dd-e063-6294a90a5dd4
spl set id: 1323a67c-b9c5-038c-e063-6394a90a5e6b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.